Job Title:
Regulatory Consultant (CMC / EU Market Experience)
📍 Location: Gurugram, India (Hybrid)
🆔 Job ID: 25101141
📅 Updated: August 20, 2025
🏢 Company: Syneos Health
🏢 About Syneos Health
Syneos Health® is a global biopharmaceutical solutions organization dedicated to accelerating customer success through integrated clinical, medical, and commercial services. Operating in 110+ countries with over 29,000 employees, Syneos has supported:
94% of FDA-approved novel drugs
95% of EMA-authorized products
200+ global studies across 73,000+ sites
💡 “Work Here Matters Everywhere” isn’t just a slogan — it’s a promise to every employee.
🌐 More info: www.syneoshealth.com
📝 Role Summary
The Regulatory Consultant (CMC) provides strategic and technical regulatory support, focusing on CMC lifecycle management for EU and global markets. This role involves preparation and review of regulatory submissions (Module 3), supporting change control assessments, and participating in product development and post-approval maintenance.
🎯 Key Responsibilities
📁 Regulatory Documentation & Submissions
Author and review Module 3 CMC documents for:
Post-approval variations
Renewals
Annual reports
Legal entity name change (LENC) variations
Ensure all submissions align with current EU regulations and global guidelines.
Develop and execute regulatory submission strategies based on change control assessments.
Conduct gap analyses and prepare product development plans based on regulatory requirements.
🗂️ Project Management & Strategy
Independently manage non-complex and complex regulatory submissions.
Operationalize day-to-day regulatory activities within defined timelines and budgets.
Contribute to proposals and estimate regulatory service components.
Support project team meetings and client communications.
Act as SME (subject matter expert) to guide internal teams and solve project-specific challenges.
🤝 Collaboration & Cross-Functional Support
Serve as regulatory lead on multidisciplinary project teams (clinical, technical, QA).
Support regulatory agency meetings, including preparation of briefing documents.
Coordinate with Quality, Regulatory, and Technical teams on change control assessments.
Prepare and deliver training materials, share regulatory best practices, and mentor junior team members.
🛠️ Compliance & Process Improvement
Ensure regulatory activities are compliant with internal SOPs and global requirements.
Contribute to SOP creation or updates.
Support internal/external audits and inspections.
Maintain accurate training records and complete all required Syneos/client training.
✅ Qualifications & Experience
🎓 Education
MS, M.Pharm, or PhD in a science-related discipline (preferred)
Equivalent industry experience considered
📅 Work Experience
Minimum 5+ years total industry experience
At least 4+ years in Regulatory Affairs, specifically in CMC submissions
Strong EU market experience is mandatory
Experience with GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE) and MEA regions preferred
🧪 Technical Skills
Demonstrated experience in:
IND, NDA, MAA, PMA, CTD submissions
Post-approval variations and lifecycle maintenance
Electronic regulatory submissions (eCTD)
Proficiency in tools such as:
Veeva RIMS, TrackWise, and other RIM systems
Microsoft Office Suite
🌍 Other Skills
Excellent verbal and written communication skills
Strong interpersonal and customer service capabilities
Detail-oriented with strong analytical and organizational skills
Ability to manage multiple concurrent projects with unique requirements
Fluent English (spoken and written)
🌟 Why Join Syneos Health
Career advancement through training, mentorship, and recognition
Inclusive "Total Self" culture encouraging authenticity and diversity
Work that impacts global health
Hybrid work flexibility and cross-functional collaboration
📌 Additional Information
Responsibilities and tasks may evolve based on project or business needs.
Equivalent experience, education, or training may substitute listed qualifications.
This role requires occasional travel (up to 25%).
Complies with global employment standards and Syneos policies including the Americans with Disabilities Act.
🚀 Next Steps
🔗 Apply Now
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